Preterm Birth Clinical Trial
Official title:
The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
Working hypothesis and aims:
To investigate whether progesterone treatment affects the incidence of preterm labor compared
to placebo, among women with 2nd trimester bleeding.
The participants will be allocated through randomization to a study or control group. Women
in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an
intra-vaginal tablet once daily while the control group will receive placebo. Both women and
medical staff will be blinded to group allocation. Treatment will commence on the day of
inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation.
Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal
outcome.
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